Plaque Control Efficacy Between Interdental Brushes Versus Dental Floss

NCT05439785 | Completed

• 1 other identifier: FatimaJDC420
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare between plaque control efficacy of interdental brushes versus interdental floss , for the prevention of periodontal disease (gingivitis) and to determine the most convenient routine interdental plaque control method amongst the two

Conditions

Periodontal Diseases; Dental Plaque

Outcome Measures

Primary Outcomes (1)

• Change from baseline in plaque score records according to Silness and Loe and O'Leary et al plaque score/index at week 6

  Silness and Loe Plaque Index and O'Leary et al plaque index are used as tools to measure plaque score by disclosing plaque, using a chewable plaque disclosing tablet. Possible score range from 0 (absence of microbial plaque) to 3 (large amount of plaque in sulcus or pocket along the free gingiva margin). Change = ( week 6 score - baseline score)

  baseline and week 6

Study Arms (2)

Group 1

EXPERIMENTAL

Dental floss

Device: Dental floss/Interdental brush

Group 2

EXPERIMENTAL

Interdental brush

Device: Dental floss/Interdental brush

Interventions

Dental floss/Interdental brush DEVICE

Initially plaque disclosing tablets were used to disclose plaque and plaque and bleeding scores will be recoded. After mechanical plaque debrided, instructions regarding the allocated interdental device given to the patient along with motivation to continue practicing good oral hygiene. After six weeks patients were recalled for reevaluation

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients above 18 years of age with gingivitis
• patients of both gender

You may not qualify if:

• patients who refuse participate in the study
• patients with systemic medical problems
• patients using medications that may affect gingival tissue (overgrowth/bleeding)
• patients habitual of betel nut/tobacco smoking/substance abuse
• patients with fluorosis or any other enamel and dentinal deformity
• pregnant women
• patients undergoing orthodontic treatment

Sponsors & Collaborators

• Fatima Jinnah Dental College: lead

Study Sites (1)

Fatima Jinnah Dental College and Hospital

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Periodontal Diseases; Dental Plaque

Interventions

Dental Devices, Home Care

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Equipment; Dentistry; Oral Hygiene; Preventive Dentistry; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Post Graduate Trainee Specialty of Periodontology,

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 30, 2022
• Study Start: April 1, 2022
• Primary Completion: May 20, 2022
• Study Completion: May 30, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)